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SalaryThis is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
The Role: Senior Sterility Assurance Specialist, ANZ Compounding
About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
What You’ll Be Doing
A great opportunity has become available for a Senior Sterility Assurance Specialist to join a critical area of the business. We are looking for a high performer with a wealth of experience to join our team working anywhere across our 7 different aseptic compounding sites within ANZ. You will be responsible for providing technical expertise and supporting ANZ Compounding sites on all Sterility Assurance aspects to ensure that all sites maintain a robust Sterility Assurance and environmental control and monitoring process that complies with Baxter’s Global Quality and local TGA Regulatory requirements.
Duties and Responsibilities:
- Support to site Environmental Monitoring and Media Fill Programs
- Investigation and identification / follow-up of corrective actions relating to Micro Out-of-Limit results
- Interact with the TGA during GMP Regulatory Inspections
- Maintenance of the Microbial Control Strategy
- Collating & analysing/trending EM data
- Subject Matter Expert for IT systems for Sterility Assurance: NOVAtek, CQI
- Liaison with Toongabbie Micro Lab as needed
- Initiating and supporting continuous improvement initiatives relating to Sterility Assurance program
- Performing impact and risk assessments for Change Controls relating to Sterility Assurance
- Providing training on Sterility Assurance related topics as needed
- Participate Internal, Corporate and Regulatory Inspections as required, including identifying & coordinating relevant follow-up actions.
- Drive and support improvement and standardization of the QMS, including coordination of continuous improvement activities.
- Other duties in support of Compounding Quality Systems as required, including support to Regional/Global Compounding.
- A microbiology or other life sciences graduate with significant with experience of aseptic processing/compounding and understanding of classified cleanrooms / Sterile environments.
- At least 5 years’ experience in implementing environmental control programs and OOL investigation and correction
- Pharma Industry / TGA experience or TGA accredited Microbiology laboratory
- Experience in data collation and analysis
- Experience in implementing and maintaining quality systems in a regulated environment, including document control, change control, nonconformance management, validation
- Experience in developing and delivering training
- Experience in validation of microbiological methods e.g. disinfectant validation, recovery studies
- Experience interfacing with regulatory inspectors/auditors
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
Apply today and experience a career that matters! Applications Close on Friday 06 March 2024.
Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .
